Kornimate/medical-research-clean huggingface dataset:
aprotinin in neonates undergoing cardiopulmonary bypass

Conditions: Cardiopulmonary Bypass; Congenital Defects; Hemostasis

Summary: this is a retrospective chart review study. the purpose of this study is to review our experience at children's healthcare of atlanta in neonates receiving aprotinin. we will examine the specific outcomes of renal dysfunction, thrombosis and mortality.

aprotinin (trasylol; bayer corporation, pittsburgh, pa), a serine protease inhibitor isolated from bovine lung, is used intra-operatively during cardiac surgery to reduce bleeding. it is thought to work by inhibiting the contact activation phase of the coagulation cascade, reducing thrombin generation, preventing fibrinolysis and attenuating cardiopulmonary bypass (cpb)-induced platelet dysfunction.though the efficacy of aprotinin in reducing blood loss in adults undergoing cpb is well established, its safety profile, specifically its association with renal dysfunction, thrombosis and long-term mortality, has been questioned. although the homeostatic derangements of cpb are more significant in pediatric patients, its efficacy and safety profiles in this patient population are actually less clear. in children undergoing re-operative cardiac surgical procedures, aprotinin has been shown to be effective in attenuating post-bypass coagulopathies and decreasing blood product exposure (4). however, little information is available for neonates undergoing cpb who receive intra-operative aprotinin especially in terms of renal dysfunction and thrombosis. all neonates who underwent cardiopulmonary bypass surgery (cpb) at children's healthcare of atlanta between march 1, 2004 and march 1, 2007 will be candidates for this retrospective chart review. notations will be made regarding those who received aprotinin and those who did not. primary end points will include post-operative renal dysfunction, need for temporary dialysis, thrombosis and in-hospital mortality. post -operative renal dysfunction will be defined as a doubling of the pre-operative creatinine level within the first 72 hours after surgery. thrombosis found during the initial hospitalization will be considered significant. chart review will gather demographic data (age, weight and type of surgery) as well as other data including cpb time, aortic cross clamp time, presence of regional perfusion, lowest temperature on cpb, time to chest closure, hours with a nirs value below 40 in the first 24 hours post-op, highest recorded lactate value, blood products administered in the first 24 hours post-op, chest tube drainage in the first 24 hours post-op, first post-op weight, time to extubation and time to icu discharge.

Eligibility criteria:
inclusion criteria: * neonates who underwent cardiopulmonary bypass (cpb) at children's healthcare of atlanta between march 2004 and march 2007. exclusion criteria: * all candidates who do not meet inclusion criteria.

Keywords: cardiology pediatrics cardiac defects cardiopulmonary bypass surgery aprotinin thrombosis renal dysfunction
factors associated with biologic dmard switching

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to understand the rheumatoid arthritis (ra) population in national integrated delivery network who are treated with first- or second-line biologic disease modifying anti-rheumatic drug (bdmard) therapy (with or without methotrexate) and to evaluate switching patterns and reasons for switching to another bdmard.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * diagnosis of ra (icd-9 714.xx) anytime during the study time period of 1/1/2007 to 10/31/2012 * patients ≥18 years of age at diagnosis date * required to have to have 6 months pre-index and 12 months post-index continuous membership and drug benefit eligibility in the database exclusion criteria: * patients less than 18 years of age on diagnosis date * if they had a diagnosis of crohn's disease, psoriasis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, regional enteritis, or anal fistula during the pre-index period * patients who had \<7 days supply of adalimumab or etanercept * patients currently in a clinical trial during our study * if patients are in the second-line cohort and have more than 1 prior bdmard
comparison of efficacy of eswl and laser lithotripsy in chronic pancreatitis with ercp

Conditions: Pancreatitis, Chronic; Pancreatic Duct Stone

Summary: this study will compare the efficacy of eswl and laser lithotripsy in the treatment of pancreatic duct stones with ercp.

chronic pancreatitis (cp) is an inflammatory disease that can causes progressive fibrosis of pancreatic tissue and eventually leads to damage of pancreatic exocrine and endocrine. according to statistics, the prevalence of cp in china is 13/10 million, which is still increasing. pancreatic duct stones are the most important pathological changes of cp. more than 50% of patients with cp are accompanied by pancreatic duct stones, which can lead to pancreatic duct obstruction, hypertension and tissue ischemia. removal of pancreatic duct stones under endoscopic retrograde cholangiopancreatography (ercp) are the first choice. ercp is effective in the treatment of pancreatic duct stones by using basket and/or balloon catheter. but in most cases, ercp is only suitable for the treatment of pancreatic duct stones (diameter \< 5mm) located in the head/body of the pancreatic duct (pd). pd stones larger than 5mm generally require extracorporeal shock wave lithotripsy (eswl) or endoscopic intraductal lithotripsy (eil) for pretreatment. eil includes electrohydraulic lithotripsy (ehl) and laser lithotripsy (ll). eswl first locates the stone by x-ray, and then uses an electromagnetic pulse generator to direct a higher-energy shock wave to the stone, so that the stone is crushed by thousands of shock waves. the principle of laser lithotripsy is to make the stone absorb strong infrared rays and generate shock waves to achieve the purpose of fragmenting the stone. in view of the fact that there is no relevant research comparing the overall efficacy of eswl combined with ercp and eil combined with ercp, it is necessary to evaluate the differences in the therapeutic effects and complications of the two for pd stones. this research helps to provide evidence-based medical evidence, guide physicians' clinical practice, improve the quality of patients' lives, and reduce the economic burden of patients.

Eligibility criteria:
inclusion criteria: * symptomatic adult patients diagnosed with chronic pancreatitis and pancreatic duct stones; * at least one stone (\>5 mm in diameter) located in the pancreatic duct of the head/body of the pancreas; * dilation of the proximal pancreatic duct. exclusion criteria: * history of ercp or eswl treatment; * suspected to have malignant tumors; * history of pancreatic surgery or gastrojejunostomy (billroth ii); * pancreatic pseudocyst with a diameter \>4cm; * bile duct stricture secondary to cholangitis or chronic pancreatitis; * acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis (including biliary pancreatitis); * coagulation dysfunction (inr≥1.5 or platelet count≤50×10\^9/l); * pregnant or breastfeeding women; * patients who refused to participate in the study.

Keywords: cholangiopancreatography, endoscopic retrograde lithotripsy
do we need high-flexing total knee arthroplasty to improve the survivorship and to decrease the incidence of osteolysis?

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine if there are any clinical or rom differences in total knee arthroplasty with standard nexgen lps prosthesis and nexgen lps-flex prosthesis.

we therefore hypothesized: (1) the survival of the nexgen lps-flex prosthesis is better than standard nexgen lps prosthesis; (2) knee function and range of motion after clinical assessment will be better in the nexgen lps-flex group; and (3) the incidence of osteolysis will be lower in the nexgen lps-flex prosthesis than standard nexgtne lps prosthesis.

Eligibility criteria:
inclusion criteria: * end-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease exclusion criteria: * inflammatory disease * patient with other lower extremity disease which may affect functional outcome * neurologic disease effecting patients lower extremity * revision surgery * patient not medically cleared for bilateral surgery
does the presence of preoperative proteinuria predict postoperative acute kidney injury in obese patients undergoing elective laparoscopic surgery?

Conditions: Acute Kidney Injury; Obesity; Proteinuria

Summary: acute kidney injury (aki) is a common, but significant complication after elective surgery which is associated with an increased risk of mortality, major adverse cardiac events, prolonged length of hospital stay, and increased cost per episode of care.

acute kidney injury (aki) is a common, but significant complication after elective surgery which is associated with an increased risk of mortality, major adverse cardiac events, prolonged length of hospital stay, and increased cost per episode of care. obese patients are at increased risk of postoperative aki when compared to normal weight patients; however current methods to assess preoperative renal function in this patient population (such as measurement of serum creatinine and calculation of the estimated glomerular filtration rate) have previously been demonstrated to overestimate their true renal function. , preoperative proteinuria has previously been determined to be predictive of the development of postoperative aki in patients of all weights undergoing cardiac surgery. published reports on the prevalence of proteinuria in obese patients span a wide range: from 8- 43%. the investigators aim to determine the predictive value of preoperative proteinuria on the development of postoperative aki in patients presenting for elective laparoscopic bariatric surgery at nyulmc. the investigators hypothesize that preoperative proteinuria will be associated with an increased incidence of aki within 48 hours after elective laparoscopic bariatric surgery. furthermore, since there is a wide range of reported prevalence of proteinuria in the bariatric patient population, part of the value of the study will be to provide a more definitive assessment of the prevalence of proteinuria in this surgical population.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * subjects undergoing elective laparoscopic bariatric surgery at nyulmc, including gastric banding, sleeve gastrectomy, and roux -en-y gastric bypass * surgery scheduled at least one day after pre admission testing visit exclusion criteria: * pre-existing end stage renal disease (crcl \<30ml/min and/or need for hemodialysis) * medical history of systemic disease known to cause proteinuria: monoclonal gammopathy, multiple myeloma, primary amyloidosis, diabetic nephropathy, acute myeloblastic leukemia, myoglobinuria, free hemoglobinuria (i.e intravascular hemolysis) * known pregnancy * diagnosis of aki within 6 months of surgery * diagnosis of cognitive dysfunction (i.e. mental retardation/developmental delay, dementia, delirium) * any subject who the study team feels would be unable to comply with all protocol procedures.
implementation of evidence-based treatments for on-campus eating disorders

Conditions: Eating Disorders (Excluding Anorexia Nervosa); Depression

Summary: the purpose of this study is to evaluate two training methods of ipt with mental health service providers in college counseling centers.

although there have been major advances in developing evidence-based psychotherapies, the adoption of such treatments by community therapists has been slow. one of the problems is the difficulty therapists in practice have in learning how to conduct an evidence-based psychotherapy. hence, this study will investigate two methods of teaching therapists interpersonal therapy (ipt), an evidence based treatment for eating disorders and depression, at 40 college or university counseling centers. current approaches to training therapists to conduct new treatments typically consist of a one or two day workshop delivered by an expert and provision of a manual for the therapy in question. recent reviews have concluded that while workshops increase therapists' knowledge, their impact on skills may be short-lived without further consultation. thus, investigators will supplement ipt training manuals and workshops by offering monthly consultation calls to participating therapists for 12 months following the workshop. the consultation calls are not designed to be case supervision per se. rather, they are to be seen as extended training on ipt. this training condition is referred to as expert consultation. the second training strategy, referred to as train-the-trainer, features expertise capacity building within each organization. there is a strong theoretical case for this implementation strategy as it is based on the principles of social cognitive theory, featuring active learning via modeling, feedback on performance, building self-efficacy, and supportive interactions among therapists developing ipt skills. this 'train-the-trainer' approach involves active learning which centers around development of an internal coach and champion, and has been recommended as the most effective means of changing actual therapist behaviors rather than just attitudes and self-reported proficiency. roth et al. have made the case that effective implementation of evidence-based treatment in routine clinical services requires that the training approximate that which characterized the research context (e.g., continuing feedback and supervision and monitoring of treatment fidelity). our train-the-trainer strategy offers a practical means of accomplishing this goal.

Eligibility criteria:
inclusion criteria: * currently employed in a participating university counseling center * providing regular student-client services
efficacy and safety of lt3001 on treating the acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: this phase ii clinical study is designed to evaluate the safety and efficacy of lt3001 in the treatment of acute ischemic stroke


Eligibility criteria:
inclusion criteria: 1. subjects aged between 18 and 80 years at screening; 2. clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment; 3.4 points ≤ nihss score ≤ 25 points at randomization; 4.subjects who are able to receive the investigational drug within 24 hours after the onset of stroke; 5.female subjects of childbearing potential or male subjects whose sexual partner are women of childbearing potential have no pregnancy plan and voluntarily take effective contraceptive measures during the study period and for 3 months after the last dose; 6.all subjects sign the informed consent form by themselves or their guardians after receiving complete study information. exclusion criteria: 1. subjects have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapy recommended by chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018 during this onset period; 2. presence of disturbances of consciousness at screening and nihss 1a ≥ 2 points; 3. neurological signs have improved rapidly and spontaneously at screening; 4. subjects who have used or are using protocol-prohibited medications after the onset; 5. subjects with pre-stroke disability; 6. subjects with intracranial hemorrhagic diseases, tumor in brain parenchyma, arteriovenous malformation, aortic arch dissection, other central nervous system lesions that may increase the risk of hemorrhage, or imaging evidence for arterial aneurysm requiring treatment; 7. massive infarction on imaging; 8. patients who are unable to cooperate due to epileptic seizure at the onset of stroke or other concomitant mental disorders or are unwilling to cooperate; 9. systolic blood pressure \> 180 mmhg and/or diastolic blood pressure \> 100 mmhg after active antihypertensive therapy; 10. acute hemorrhage tendency; 11. blood glucose level \ 400 mg/dl; 12. active visceral hemorrhage; 13. lactating or pregnant subjects, or women of childbearing potential with positive pregnancy test results; 14. international normalized ratio \> 1.7 or prothrombin time \> 15 s; 15. subjects with a history of serious hypersensitivity; 16. subjects who experienced ais, ich, acute myocardial infarction or serious head trauma before screening; 17. subjects who underwent any major surgery before screening; 18. subjects with a history of active digestive ulcer before screening; 19. subjects who experienced hemorrhagic disease before screening; 20. subjects who underwent arterial puncture at the site not easy for hemostasis by compression before screening; 21. serious hepatic impairment or serious renal insufficiency; 22. subjects who have participated in another investigational study and used investigational product before screening; 23. other conditions unsuitable for participation in this study determined by the investigator.
the tolerability , pharmacokinetics and pharmacodynamics study of hec96719 tablets in healthy adult subjects

Conditions: Nonalcoholic Steatohepatitis (NASH)

Summary: this study is a safety, tolerability, and pharmacokinetics phase ⅰstudy of hec96719, in healthy subjects.this study is the healthy adult subjects single ascending-dose research

this study will evaluate the safety and tolerability of escalating single oral doses of hec96719, and characterize the single-dose pharmacokinetics (pk) of hec96719. participants will receive either hec96719 or hec96719 placebo.

Eligibility criteria:
inclusion criteria: * willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study. * female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication. * when signing the informed consent, 18 years old ≤the age≤45 years old(including the critical value), gender is not limited. * male body weight ≥50kg, female body weight ≥45kg, and body mass index (bmi) in the range of 18-28 kg/m2 (including the critical value). * no clinical significance of vital signs, physical examination, laboratory examination, electrocardiogram, ultrasound abdomen and chest x-ray (posterior and anterior) results. exclusion criteria: * positive for viral hepatitis (including hepatitis b and c), hiv and syphilis. * those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations. * intemperant or regular drinkers within 3 months prior to the study, i.e., those who consumed more than 21 units of alcohol per week (1 unit =360ml beer or 45ml spirit with 40% alcohol or 150ml wine), or those who were positive on the alcohol breath test. * those who had a blood donation or blood loss of \>400ml within one month before taking the study drug. * those who have participated in clinical trials of other drugs within 3 months before randomization. * subjects considered by the investigator to have other factors unsuitable for participation in this study.
intrathecal dexamethasone and atropine on morphine induced post-operative nausea and vomiting on caesarean section

Conditions: Morphine Adverse Reaction

Summary: pain is a major problem during the postoperative period and can be considered as a challenge for the anesthesiologist. low dose intrathecal morphine is proven efficient as a mode to reduce postoperative pain. morphine has many complications like post-operative nausea and vomiting (ponv). the investigators will investigate the utility of intrathecal (it) atropine and dexamethasone for prevention of morphine induced ponv as a primary outcome in parturient undergoing cs under spinal bupivacaine anesthesia plus morphine sulfate as an adjuvant.

pain is a major problem during the postoperative period and can be considered as a challenge for the anesthesiologist. low dose intrathecal morphine is proven efficient as a mode to reduce postoperative pain in many surgical areas including caesarean delivery. morphine has many complications namely pruritus, and post-operative nausea and vomiting (ponv). the other risk factors for the development of ponv include female gender, non-smoker status, general anesthesia with inhalational anesthetics and surgical factors (duration and type of surgery). the supplementation of morphine, however raises the occurrences of postoperative nausea and vomiting (ponv) in these patient to tackle this problem, the investigators have to use the combination therapy of antiemetics like a serotonin receptor antagonist of either intravenous (iv) ondansetron or granisetron with iv dexamethasone is administered after the administration of intrathecal morphine. dopamine receptor antagonists e.g. droperidol and metoclopramide are commonly used, but they carry the risk of extrapyramidal symptoms.

Eligibility criteria:
inclusion criteria: 1. female 2. 18-45 years old 3. asa: 1, 2 4. elective caesarean section under spinal anaesthesia. exclusion criteria: 1. patient refusal. 2. contraindications to spinal anaesthesia as coagulopathy, infection at site of injection, hemodynamic instability and uncooperative patient. 3. contraindications to administration of morphine as asthmatic patient and hypersensitivity and contraindications to any of the study drugs. 4. adult-emergency cs as there is no time for preparation and risk on fetus and mother for time consuming